Manufacturing Quality Assurance (MQA) Associate performs routine inspections of production activities. The Associate is available on the Operations floor working together with other MQAs and Operations departments to ensure compliance issues are detected and solved in real time. The Associate performs in-process reviews of production batch record and logbooks.

Main Responsibilities:

• The MQA Associate monitors batch processing activities for their compliance with the established procedures, batch records and cGMP requirements:
• Routine inspections and documentation of Operations floor activities, systems, utilities, and facilities as per the checklists.
• Routine review of logbooks and Batch records including the confirmation of Critical Parameters.
• Line clearances as per Operations schedule.
• The MQA Associate helps with:
• Return to Service Actions
• Review of critical systems/utilities Alarms
• Work Order /Preventative Maintenance Review
• Calibration Record Review
• If assigned, the MQA Associate participates in departmental and interdepartmental teamwork and performs other tasks or assignments as directed by the QA Supervisor/Manager. This may include writing deviations, performing investigations, writing change controls, and executing action items, revising SOPs and other GMP documents.
• The MQA Associate follows and promotes organizational safety policy.

Requirements:

College degree or equivalent education preferred /Equivalent experience required.

Pharmaceutical experience in Quality or Operations department preferred.

Experience with biologics Quality Assurance or Operations plus.

Plasma fractionation, aseptic filling, and labeling experience plus.

Note: This position may require the labeling, packaging or movement of hazardous (flammable, corrosive, toxic, etc.) waste within the facility. If so, this employee would be trained. In lieu of HAZWOPER training, the employee will receive training on the requirements of the New York State hazardous waste management regulations pursuant to 6 NYCRR §373-3.2. All employees that have received the above-mentioned training upon hire will receive annual refresher training that covers the OSHA HAZWOPER standard and the personnel training requirements of the NYSDEC.

The expected pay for this position is between $22-24ph

Job Type: Full-time

Pay: $22.00 - $24.00 per hour

Benefits:

• 401(k)
• 401(k) matching
• Health insurance
• Paid time off

Experience level:

• 2 years

Schedule:

• 12 hour shift
• Monday to Friday
• Night shift
• Weekends as needed

Work setting:

• In-person
• Manufacturing facility

Work Location: In person